Early Loading of Dental Implants; A Prospective Study in the Mandibular First Molar Area.
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ClinicalTrials.gov Identifier: NCT02836964 |
Recruitment Status : Unknown
Verified June 2017 by Aladdin Al-Ardah, DDS, MS, Loma Linda University.
Recruitment status was: Recruiting
First Posted : July 19, 2016
Last Update Posted : June 16, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dental Implants | Device: Dental Implant | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Early Loading of Dental Implants; A Prospective Study in the Mandibular First |
Actual Study Start Date : | February 1, 2017 |
Estimated Primary Completion Date : | February 2018 |
Estimated Study Completion Date : | March 2018 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Loading of Dental Implants after 4 weeks
A total of 12 titanium implants with a modified SLA surface (BLT SLActive®, Institute Straumann AG, Basel, Switzerland) will be placed in the mandibular first molar. for this group. After 4 weeks definitive crown will be placed. |
Device: Dental Implant
Dental implant |
Active Comparator: Loading of Dental Implants after 3 months
A total of 12 titanium implants with a modified SLA surface (BLT SLActive®, Institute Straumann AG, Basel, Switzerland) will be placed in the mandibular first molar for this group. After 3 months definitive crown will be placed
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Device: Dental Implant
Dental implant |
- marginal bone level changes by using periodical radiography. [ Time Frame: assessment of marginal bone level (MBL) will be made at the time of implant placement and after 6 months ]Standardized radiographs using customized jig and long cone paralleling technique, using Rinn Film holders (Dentsply, Germany) for assessment of marginal bone level (MBL) will be made at the time of implant placement, as well as at 3 and 6 months 3. Changes in interproximal crestal bone levels will be measured and recorded using NIH Image Program Software(http:/rsb.info.nih.gov/nih-image)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged 18 years or older.
- Willingness to comply with all study requirements.
- Partially edentulous in the in mandibular first molar with presence of the mandibular second molar
- Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias.
- Free from soft tissue mucosal lesions, caries, and active periodontitis at the time of implant insertion.
- Sufficient alveolar bone volume at the implant recipient site at the time of the insertion.
- Adequate oral hygiene. Full-mouth plaque score (FMPS) (O'Leary et al. 1972) full-mouth bleeding score (FMBS) (Ainamo & Bay 1975) record as the percentage of surfaces, four per each tooth, patients need to have controlled their periodontal conditions (FMPS 20%, FMBS 20%).
Exclusion Criteria:
- Pregnant or lactating females.
- Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus.
- History of irradiation in the head and neck area.
- Smoking.
- Untreated periodontitis.
- Alcohol or drug abuse.
- History of Intravenous Bisphosphonate.
- Previously augmented or tooth extraction at the intended implant recipient site within the last 6 months.
- The use of regenerative procedures in conjunction with implant placement.
- Presence of residual roots at the implant recipient site.
- Stomatological diseases.
- Clinical signs of bruxism.
- Initial stability at least 35Ncm

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836964
Contact: Bader s albader, DDS | 9095584983 ext 0000 | balbader@llu.edu |
United States, California | |
Loma Linda Health | Recruiting |
Loma Linda, California, United States, 92350 |
Principal Investigator: | Aladdin j Alardah, DDS | associate professor |
Responsible Party: | Aladdin Al-Ardah, DDS, MS, Principal Investigator, Loma Linda University |
ClinicalTrials.gov Identifier: | NCT02836964 |
Other Study ID Numbers: |
5160039 |
First Posted: | July 19, 2016 Key Record Dates |
Last Update Posted: | June 16, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |